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Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma (DLBCL)

This study is currently recruiting participants.
Verified April 2013 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01186978
First received: August 19, 2010
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

This study will evaluate whether a reduction in the radiation dose and field size will maintain a high rate of local control while minimizing the risk of acute and late toxicity.

Hypothesis- The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy while maintaining high rates of local control in patients who had a negative PET scan following rituximab-containing chemotherapy.


Condition Intervention
Diffuse Large B-cell Lymphoma
 Radiation: Radiation Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Actuarial Freedom from Local Failure [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: October 2010
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Radiation Therapy
    1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic documentation of diffuse large B-cell lymphoma, or any of its variants as defined in the WHO classification
  • Completion of at least 4 cycles of a rituximab-containing, anthracycline-based combination chemotherapy
  • Negative post-chemotherapy (or interim) PET scan
  • Absolute neutrophil count greater than 1500 and platelet count greater than 40,000
  • Negative pregnancy test in women of child-bearing potential

For patients with HIV/AIDS, the following must be true:

  • The patient is compliant on combination anti-retroviral therapy (CART)
  • The patient has CD4 count ≥ 200 at time of diagnosis

Exclusion Criteria:

  • Any contraindications to irradiation
  • Primary CNS lymphoma
  • HIV/AIDS
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186978

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Christopher Kelsey, MD     919-668-5213     christopher.kelsey@duke.edu    
Principal Investigator: Christopher Kelsey, MD            
Durham Regional Hospital Recruiting
Durham, North Carolina, United States, 27704
Contact: Bridget Koontz, MD     919-470-8600        
Principal Investigator: Bridget Koontz, MD            
Duke Raleigh Hospital Enrolling by invitation
Raleigh, North Carolina, United States, 27609
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Christopher Kelsey, MD Duke University Medical Center, Radiation Oncology
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01186978     History of Changes
Other Study ID Numbers: Pro00025164
Study First Received: August 19, 2010
Last Updated: April 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 22, 2013